YASARGIL VARIO A.FCPS.STD.TI.90/220MM

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: THE APPLIERS ARE AVAILABLE FOR INVESTIGATION IN DECONTAMINATED CONDITION. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. AESCULAP TECHNICAL SERVICE (ATS) CARRIED OUT THE INVESTIGATION. JAW DIMENSIONS TESTING: FT412T PASSED, FT402T PASSED. BRANCH DIMENSIONS TESTING: FT412T PASSED, FT402T FAILED. FURTHERMORE, FUNCTIONAL TESTS OF THE LOCK MECHANISMS WERE CARRIED OUT. BOTH MECHANISMS WORK WITH INTERRUPTIONS, DEPENDING ON HOW THE BRANCHES ARE PRESSED AND IN WHICH POSITION THE MOVEABLE DISTAL END IS. THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. BOTH LOCKING MECHANISMS DO NOT WORK RELIABLY. THE LOCKS ARE ADAPTED DURING MANUFACTURING PROCESS TO ENSURE A PROPER FUNCTION OF THE APPLIER. THEREFORE, MOST LIKELY THEY HAVE BEEN BENT E.G. DUE TO IMPROPER HANDLING OR AN OVERLOAD SITUATION DURING HANDLING OR REPROCESSING. A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A YASARGIL VARIO FORCEPS. ACCORDING TO THE COMPLAINT DESCRIPTION: "BRAIN TUMOR SURGERY. WHEN THE CLIP WAS PUT IN PLACE BY THE SURGEON, THE RATCHET REMAINED BLOCKED AND COULDN'T CLOSE THE CLIP. AT THE END OF THE INTERVENTION, THE SURGEON HAS TESTED THE CLAMP, AND FOUND AGAIN THE SAME PROBLEM. HAEMORRHAGIC RISK AND DELAY, BUT CONFIRMATION THAT THERE WAS NO PATIENT INCIDENCE. THE DEVICE USED DURING THE INTERVENTION WAS AN FT402T. BUT REVISION REQUEST FOR THE FT412T." THERE WAS NO PATIENT HARM. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2019-00569 (400439439 - FT402T).